Hyaluronic Gel vs Chlorhexidine in Periodontal Patients

NCT05312606 | Completed

• 1 other identifier: 2022-AFTORAL PARO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy. After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder. After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:

• Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days.
• Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days. The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3). Professional oral hygiene procedures will be repeated at T2 and T3. At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
• Gingival Recession (GR)
• Probing Pocket Depth (PPD)
• Bleeding on Probing (BoP)
• Clinical Attachment Level (CAL)
• Plaque Control Record (PCR)
• Tooth Mobility (TM)

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (5)

• Change in Probing Pocket Depth (PPD)

  Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.

  Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

• Gingival Recession (R)

  Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin.

  Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

• Change in Bleeding on Probing (BOP%)

  Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100

  Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

• Change in Clinical Attachment Level (CAL)

  Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites.

  Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

• Change in Plaque Control Record (PCR%)

  Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100

  Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)

Study Arms (2)

Trial Group

EXPERIMENTAL

Home treatment with hyaluronic acid.

Other: Aftoral Oral gel

Control Group

ACTIVE COMPARATOR

Home treatment with chlorhexidine.

Other: Unidea Chlorhexidine digluconate mouthwash 0.20%

Interventions

Aftoral Oral gel OTHER

Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).

Trial Group

Unidea Chlorhexidine digluconate mouthwash 0.20% OTHER

Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of periodontitis sites according to the 2017 World Workshop classification system
• absence of systemic, metabolic, or autoimmune diseases
• compliant patients

You may not qualify if:

• neurological, psychiatric, or mental disorders
• patients taking bisphosphonates within the last 12 months
• patients taking antibiotics during the study period
• pregnant or breastfeeding women
• patients undergoing anticancer treatment

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The examiner assessing the periodontal clinical parameters is blinded to the treatment allocation, while participants are aware of the assigned domiciliary treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 5, 2022
• Study Start: April 4, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 5, 2022
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)